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Participants who received facilitated telemedicine initiated DAA therapy faster and had greater cure rates than those who were referred to an off-site hepatitis specialist.
Health care access is a longstanding issue among many underserved patient populations, including individuals with opioid use disorder. However, integrating facilitated telemedicine into opioid treatment programs may provide a promising solution for overcoming barriers to care, according to findings from a multisite, nonblinded, pragmatic clinical trial.1
Results published in JAMA showed that compared with off-site referral to a hepatitis specialist, hepatitis C virus (HCV) treatment administered through facilitated telemedicine integrated into opioid treatment programs resulted in significantly faster initiation of direct-acting antiviral (DAA) therapy and greater cure rates among HCV-seropositive persons with opioid use disorder.1
“These groundbreaking results published in JAMA highlight the power of novel approaches in tackling chronic conditions in underserved populations,” Allison Brashear, MD, vice president for health sciences and dean of the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo, said in a press release.2 “The findings pave the way for significant improvements in the lives of participants and offer hope for similar successes in addressing other diseases.”
The World Health Organization (WHO) estimates there are a global 58 million people infected with chronic HCV, identifying injection drug use through the sharing of equipment as a risk factor for transmission. Despite being a curable infection, access to treatment remains an issue for many people with HCV. To address this, the WHO recommends testing, care, and treatment be provided by trained non-specialist doctors and nurses using simplified service delivery in primary care, harm reduction services, and prisons. However, real-world data about the impact of such an approach remains limited.3
To assess the impact of opioid treatment program-integrated facilitated telemedicine on HCV treatment access and subsequent cure rates, investigators conducted a prospective, cluster-randomized clinical trial using a stepped wedge design at 12 opioid treatment programs throughout New York. HCV-infected individuals were enrolled between March 1, 2017, and February 29, 2020. For inclusion, they were required to be actively enrolled in the opioid treatment program for 6 months, have detectable HCV RNA, be ≥ 18 years of age, and have insurance coverage for DAAs.1
Each of the 12 programs began with off-site referral and every 9 months, 4 sites were randomly selected and transitioned to facilitated telemedicine during 3 steps without participant crossover. In each of the periods, 13 participants were enrolled from each site, resulting in a projected sample of 12 clusters with 624 participants. In total, 602 participants were recruited and assigned to usual care with an off-site hepatitis specialist referral (n = 312) or integrated facilitated telemedicine with an on-site study case manager at the opioid treatment program (n = 290).1
The primary outcome was sustained virologic response (SVR), defined as undetectable HCV RNA 12 weeks after treatment cessation. Predefined secondary outcomes included a comparison of treatment initiation and completion rates, participant satisfaction with health care delivery, and treatment adherence rates between groups. Investigators also examined HCV reinfection as an exploratory outcome.1
Among the study cohort, the majority of participants were male (61.3%) and White (50.8%). The mean age of participants in the telemedicine group was 47.1 (Standard deviation [SD], 13.1) years compared to 48.9 (SD, 12.8) years in the referral group, with investigators pointing out baseline characteristics were generally similar between the 2.1
In the group who received telemedicine care, 268 (92.4%) participants initiated treatment compared with 126 (40.4%) participants who received a referral. Among participants who initiated therapy, investigators noted the observed SVR rate was similar between the groups (91.8% in telemedicine vs 84.1% in referral).1
Intention-to-treat cure percentages were 90.3% in telemedicine and 39.4% in referral, with an estimated logarithmic odds ratio of the study group effect of 2.9 (95% CI, 2.0-3.5; P <.001) with no effect modification.1
Investigators also pointed out a significantly shorter time between screening and initial appointments among participants who received facilitated telemedicine compared with those who received a referral (14 days vs 18 days, respectively; test statistic = 2.1; P = .04), additionally highlighting a shorter duration between the initial visit and DAA initiation among participants in the telemedicine group (49.9 days vs 123.5 days, respectively; test statistic = 3.85; P <.001). Investigators noted illicit drug use decreased significantly among cured participants, regardless of which group they were in (referral 95% CI, 1.2-4.8; P = .001; telemedicine 95% CI, 0.3-1.0; P <.001).1
Minimal reinfections (n = 13) occurred, including 3 in the referral group with a total follow-up of 162.0 person-years and 10 in the telemedicine group with a total follow-up of 365.2 person-years. Across both groups, participants rated health care delivery satisfaction as high or very high.1
“Our findings show that this kind of research can be done in unconventional settings and that leveraging the trust that patients have in these treatment programs can be very helpful,” lead study investigator Andrew Talal, MD, professor in the department of medicine at Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo, said in a press release.2
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